Kornimate/medical-research-clean huggingface dataset:
an observational study of avastin (bevacizumab) in patients with ovarian cancer

Conditions: Ovarian Cancer

Summary: this observational study will collect data about safety in female patients with advanced ovarian epithelial cancer with measurable residual disease after surger y. the treating physician has decided to treat the patients with avastin (bevaci zumab) in combination with chemotherapy followed by avastin monotherapy accordin g to the local label. data will be collected for 72 weeks.


Eligibility criteria:
inclusion criteria: * female patients over 18 years of age * histologically confirmed advanced epithelial ovarian cancer * confirmed ascites prior to surgery * residual disease after surgery * patients are chemotherapy naïve or have received only one prior line of treatment for their disease * international federation of gynecology and obstetrics (figo) stage iiib or iv disease * eastern cooperative oncology group (ecog) performance status \<=2 * patients must meet treatment eligibility requirements according to treating physician and summary of product characteristics (smpc) criteria for avastin plus chemotherapy. exclusion criteria: * pregnancy or lactation * low grade tumors, since this does not necessarily requires systemic treatment. complete surgical resection * uncontrollable hypertension * unexplained bleeding * known hypersensitivity to any components of bevacizumab * all contraindications specified in the respective summary of product characteristics (smpc) and/or local labelling of avastin and the corresponding chemotherapy must be adhered to by the physician.
combined therapy for hepatocellular carcinoma >3-<5 cm

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to compare the safety and efficacy of combined therapy with conventional transarterial chemoembolization (ctace) + microwave ablation (mwa) versus only tace or mwa for treatment of hepatocellular carcinoma (hcc) \>3-\<5 cm.

this study aims to compare the safety and efficacy of combined therapy with conventional transarterial chemoembolization (ctace)+microwave ablation (mwa) versus only tace or mwa for treatment of hepatocellular carcinoma (hcc) \>3-\<5 cm. this randomized controlled trial screened 278 patients with hcc \>3-\<5 cm. patients were randomized into three groups: 90 underwent tace (group 1); 95 underwent mwa (group 2); and 93 underwent combined therapy (group 3). patients were followed-up with contrast-enhanced ct or mri. images were evaluated and compared for treatment response and adverse events based on modified response evaluation criteria in solid tumor. serum alpha-fetoprotein (afp) concentration was measured at baseline and during every follow-up visit.

Eligibility criteria:
inclusion criteria: 1. solitary hcc \>3-\<5 cm 2. absence of extra-hepatic metastases 3. absence of a history of encephalopathy or refractory ascites 4. child-pugh class a or b cirrhosis. exclusion criteria: 1. poor patient compliance 2. child-pugh class c cirrhosis 3. severe coagulation disorders 4. portal vein thrombosis 5. renal impairment (6) previous local ablation therapy of hcc

Keywords: combined therapy; hepatocellular carcinoma
a clinical investigation to assess the effectiveness of benzocaine condoms in healthy adult men

Conditions: Ejaculation Delayed

Summary: this investigation is designed to evaluate the effectiveness of two nrl condoms with benzocaine paste compared with a standard nrl control.

in this clinical investigation, two nrl condoms with benzocaine paste (test condom a and test condom b) will be evaluated against a standard nrl male condom (control condom) in prolonging time to ejaculation in healthy adult men.

Eligibility criteria:
inclusion criteria: 1. subjects and their female partners between the ages of \>=18 years and =\<60 years. 2. subjects and their female partners must have no health condition in their medical history. 3. subject must be sexually active having regular intercourse (a minimum frequency of once a week). 4. subjects in a stable, monogamous, sexual relationship with the same female partner for more than or equal to 3 months. 5. subject's female partner should already be on an established other highly effective form of non-barrier contraception, unless post-menopausal. exclusion criteria: 1. subject or his female partner with alcohol or drug abuse. 2. subjects and their female partners with anemia, coronary artery disease, impaired cardiac conduction, pulmonary disease, diabetes, and renal or hepatic disease. 3. subjects and their female partners with a risk of methaemoglobinemia / complications related to ester anaesthetics which could trigger methemoglobinemia. 4. subject and/or his female partner with urological disease or genitourinary surgery; ongoing significant psychiatric disorder not controlled by medication; history of surgery or injury to the pelvis, retroperitoneal surgery, radiotherapy, multiple sclerosis, spinal cord injury, chronic inflammation of the prostate or urethra; relevant genital surgery; a female partner with vaginal complaints; any broken skin or wounds in the genital area. 5. subjects on medication that is contraindicated, which may affect erection. 6. subject and/or his female partner have any medication which may affect the safety of the subject, including but not limited to benzocaine drug interactions such as sulphonamides and cholinesterase inhibitors. 7. subject with premature ejaculation, erectile dysfunction, hypo or hyperthyroidism, hypogonadism, hyperprolactinemia, ejaculatory dysfunction, haemorrhagic disorder, hepatitis b or c, human immunodeficiency virus (hiv) infection or having had penile implant surgery. 8. subjects and their female partners who have any relevant history of allergy including local anaesthetics, parabens, paba, commercial hair dyes, paraphenylenediamine, lubricants and latex.
nutritional supplements on blood pressure 2008

Conditions: Hypertension

Summary: three different supplements will be used in the study (fruits and vegetable powders, whey protein and calcium) for patients with hypertension. the null hypothesis was that the supplements had no effects on participants' blood pressure.

hypertensive participants will be randomly assigned into three groups. the first group of participants will take the fruits and vegetable powders mixed with water. the second group takes whey protein and the third group takes calcium pills. blood pressure and heart rate variability will be measured every two weeks for three months.

Eligibility criteria:
inclusion criteria: * age 20-70 * hypertensive male and female subjects. exclusion criteria: * severe cardiovascular and renal conditions. * pregnancies and taking medications.

Keywords: hypertension supplement hrv
fatigue management programs for people with ms

Conditions: Multiple Sclerosis

Summary: this is a multi-site randomized clinical trial comparing 3 modes of delivering the managing fatigue course for reducing fatigue in individuals with multiple sclerosis (ms). the primary hypothesis is that the teleconference and internet versions of the course will be noninferior to the one-on-one, in person version in terms of the primary outcome of fatigue and secondary outcome of quality of life.

fatigue is one of the most common and debilitating symptoms of multiple sclerosis (ms). ms fatigue can impact all aspects of quality of life, including physical, mental, and social function. ms fatigue is a profound barrier to participating in meaningful activities, such as employment and hobbies. currently, the fda has not approved medications for ms fatigue in the united states (us). however, there are empirically tested, non-pharmacological strategies that can support people with ms in reducing the impact of fatigue. thus, the aim of the study is to compare 3 modes of delivering the managing fatigue course-2 telerehabilitation formats (teleconference and internet) and 1-to-1, in-person format (traditional mode of clinical service delivery)-upon outcomes important to people with ms, i.e., fatigue and its impact on physical, mental, and social function. the intervention arms will focus on reducing fatigue as a strategy to directly improve physical, mental and social functioning.

Eligibility criteria:
inclusion criteria: * self-report diagnosis of ms * age ≥ 18 years * fatigue severity scale score ≥ 4 * ability to speak english exclusion criteria: * individual must be capable of providing consent (assessed with questionnaire) * unable to access the internet or unable to travel to in-person sessions

Keywords: fatigue wellness multiple sclerosis quality of life
study to investigate effect of a new drug (pf-00446687) in post-menopausal women who suffer from sexual dysfunction.

Conditions: Female Sexual Dysfunction

Summary: the purpose of this study is to investigate the effect of up to 200 mg of pf-00446687 on acute sexual arousal and sexual interest in post menopausal females, as well as examining the safety and toleration of the drug.


Eligibility criteria:
inclusion criteria: * women who have evidence of female sexual arousal disorder. * women who experience personal distress due to female sexual dysfunction. * post menopausal women aged between 45 and 65 years. exclusion criteria: * women whose sexual dysfunction is limited to certain types of stimulation, situation or specific partners. * women who experience pain with sexual intercourse or who have a sexual aversion disorder. * women suffering from female sexual dysfunction where the cause is treatable, for example inadequately controlled diabetes or thyroid dysfunction.
post-market safety reassessment of ulinastatin for injection

Conditions: Adverse Reaction to Drug

Summary: 1. investigate the application of ulinastatin(uti) in real practice clinic.(eg:population character, usage and dosage, course of treatment,etc ) 2. analysis the incidence of adverse drug reactions /adverse events of ulinastatin, collect the main clinical manifestations, treatment, outcome, influence factors; provide evidence for improving the recommended medication plan of ulinastatin. 3. evaluate the safety of ulinastatin , obtain scientific conclusion , and provide evidence for appropriate medication to administration department of health authority.

in order to find out the application of ulinastatin in real practice clinic , identify the high risk group for adverse event/adverse drug reaction and calculate the adverse event/adverse drug reaction incidence rate, a large sample size clinical trial has been designed. this trial is an observational study. the investigators would screen several hospitals from different provinces and prospectively collect the main clinical manifestations,treatment, outcome, influence factors about patients using ulinastatin either in general clinical departments or in icu. this study would be expected to provide evidence for appropriate medication to administration department of health authority.

Eligibility criteria:
inclusion criteria: * patients with ulinastatin treated exclusion criteria: * not applicable
dynamic mri of the behaviour of female pelvic floor

Conditions: Stress Urinary Incontinence; Genital Prolapse

Summary: the purpose of this study was to test the suitability of dynamic magnetic resonance imaging for the pelvic floor floor, bladder neck and urethra in healthy volunteers, in stress incontinent patient and in women with genital prolapse.

traditional methods for evaluation of urinary incontinence in women include urodynamics, cystourethroscopy, cystourethrography and ultrasonography.magnetic resonance imaging (mri) offers a new tool for evaluation of morphology and function of the urogenital compartment of the female pelvis. moreover, mri gives opportunity to study function of the pelvic floor organs in terms of mobility and reactions during different physiological and provocative activities. the aim of the present study was by means of dynamic mri to evaluate the behaviour of the mid-urethra, bladder neck, cervix and rectum in different maneuvers in three different study groups. sixteen healthy volunteers with no complaints of urinary symptoms or urogenital prolapses, 42 stress urinary incontinence patients and 16 women with third degree genital prolapse were examined respectively.

Eligibility criteria:
inclusion criteria: * healthy women without any urogenital symptoms * stress urinary incontinence ( group ii ) * genital prolapse of third degree ( group iii) exclusion criteria: * previous incontinence or prolapse surgery * lower urinary tract anomaly * current uti or \> 3 uti episodes within the past year * previous radiation therapy of the pelvis * active malignancy * neurogenic disease which can be associated with bladder disorders * patient unable to understand the purpose of the study * patient immobile

Keywords: stress urinary incontinence tension free vaginal tape tension free vaginal tape obturator genital prolapse
use of granulocyte colony-stimulating factor for the treatment of recurrent implantation failure in ivf patients

Conditions: Infertility

Summary: the investigators use granulocyte colony-stimulating factor (gcsf) for the treatment of recurrent implantation failure in ivf patient with cause unknown or due to thin endometrium. several studies showed that gcsf improves embryo development and implantation and increase pregnancy rate.

the investigators use granulocyte colony-stimulating factor (gcsf) for the treatment of repeated implantation failure (5 cycles) in ivf patient with cause unknown or due to thin endometrium. we intend to treat with gcsf during the ivf cycle if thin endometrium (\<6 mm) is the cause for the treatment failure, and during the implantation window if cause unknown.

Eligibility criteria:
inclusion criteria: 1. women after 5 failures in ivf cycles with cause unknown. 2. women after 5 failures in ivf due to thin endometrium (\<6 mm) and unresponsive to estrogen supplements. exclusion criteria: 1. history of hematology disease 2. allergy to gcsf 3. neutrophilia 4. severe lower back pain 5. liver dysfunction 6. hyperuricemia 7. a recent febrile disease or pneumonia 8. rheumatoid arthritis 9. sickle cell disease-

Keywords: improving pregnancy rate and endometrial thickness
immunogenicity study of wockhardt's insulin lispro/lispro mix basal bolus regimen in type 1 diabetics

Conditions: Type I Diabetes

Summary: this is a randomized, parallel group comparison of the immunogenicity safety of wockhardt's insulin analogue lispro and lispro mix with eli lilly's insulin analogue humalog® and humalog® mix in patients with type 1 diabetes mellitus

to evaluate and compare the immunogenicity safety of wockhardt's insulin analogue lispro and lispro mix with eli lilly's insulin analogue humalog® and humalog® mix in type i diabetic patients.

Eligibility criteria:
inclusion criteria: 1. patients who understand the nature of the study and are willing to provide written informed consent. 2. patients who have been pre-diagnosed as cases of type-1 diabetes for a period not less than 1 year 3. male or female patients ≥ 18 and \< 55 years of age. 4. patients with body mass index (bmi) of 18.0 to 30.0 kg/m2 5. patients who are cooperative, reliable, and agree to have regular injections of insulin and are willing to comply with protocol procedures. 6. ability to use the self glucose-monitoring device and to self inject insulin. exclusion criteria: 1. females who are pregnant or lactating, or not practicing adequate contraception. 2. a patient with compromised hepatic or renal function 3. a patient who is an employee of the investigator, or a patient who has a direct involvement with the trial or other trials under the direction of the investigator. 4. a patient who has been treated with other investigational agent or devices within the previous 30 days, has planned use of investigational drugs or devices, or has been previously randomized in this trial. 5. a patient with history or evidence of allergy to insulin preparations. 6. a patients who is currently receiving or has received, within the last year, any immunomodulator medications. 7. patients unlikely to comply with the study protocol e.g. unable to return periodically for subsequent visits. 8. patients who are judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned.

Keywords: type i diabetes wockhardt's insulin analogue lispro humalog® humalog mix wockhardt biosimilar phase 3
efficacy and safety of alogliptin in participants with type 2 diabetes in japan

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study was to evaluate the dose-response relationships of alogliptin, once daily (qd) to an α-glucosidase inhibitor, three times daily (tid), to determine the optimal clinical dose for type 2 diabetic patients.

both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus. takeda is developing syr-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. alogliptin is an inhibitor of the dipeptidyl peptidase iv (dpp-iv) enzyme. dpp-iv is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. it is expected that inhibition of dpp-iv will improve glycemic control in patients with type 2 diabetes. to evaluate the long-term safety and efficacy of alogliptin, participants in the present study could enter a long-term extension study syr-322/oct-001 (nct01263496) that was planned separately.

Eligibility criteria:
inclusion criteria: * a glycosylated hemoglobin (hba1c) value of 6.5% or more and below 10.0% 4 weeks after the start of screening(week -4). * a hba1c differences within 10.0%\* (\*rounded off to the first decimal point) at the start of screening (week -8) and 4 weeks after the start of screening (week -4) from the hba1c value at the start of screening. * was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of screening (week -8). exclusion criteria: * received any antidiabetic drug within the last 4 weeks before the start of screening (week -8) or during screening.

Keywords: diabetes mellitus - type 2 diabetes mellitus drug therapy
implementation of evidence based practices for colonoscopy: the strategies to improve colonoscopy study

Conditions: Colonoscopy

Summary: the purpose of this study is to compare the effect of physician education about evidence based practices for colonoscopy alone, versus physician education plus a multi-component staff implementation strategy to improve adequacy of bowel preparation. additionally the investigators will examine implementation factors that influence adoption of the evidence based practices.

over 14 million colonoscopies are performed annually in the u.s. about 25% of patients that undergo colonoscopy have inadequate bowel preparation, an impediment to identifying cancer and pre-cancerous growths. the adenoma miss rate for patients with inadequate bowel preparation can be as high as 48%. the primary goal of the strategies to improve colonoscopy (stic) study is to conduct formative research on a multi-component implementation strategy to increase staff adoption of evidence-based practices (i.e. split-dosing of the medication, low-literacy materials, teach-back) for educating patients and improving the adequacy of bowel preparation for colonoscopy. investigators will compare the effect of physician education about evidence based practices for colonoscopy alone, versus education plus a staff implementation toolkit to improve quality of colonoscopy (i.e. adequacy of bowel preparation). physicians in both study groups will receive education on the evidence-based practices. staff who work for physicians in the initial intervention group will receive a multi-component implementation strategy for the evidence-based practices, consisting of staff education, a supply of low-literacy patient education materials for split-dosing the medication of their choice, poster and pocket-card with teach-back prompts, a consultation to integrate materials and teach-back into workflow, and a website with additional training and patient materials. the initial intervention period will be followed by a replication study where the delayed intervention group will receive the intervention. investigators will compare change in colonoscopy quality outcomes from before to after implementation of interventions for the two study groups: a) overall; and for b) medicaid versus other insurance using administrative and medical record data with interrupted time series analysis. investigators will also examine factors that influence adoption of the evidence based practices using structured physician, staff and patient surveys.

Eligibility criteria:
inclusion criteria: * physicians who perform colonoscopies at 6 participating endoscopy centers * staff who work for participating physicians and provide education for bowel preparation before colonoscopy * patients who had an outpatient colonoscopy at a participating endoscopy center during study period exclusion criteria: - none

Keywords: quality of healthcare colorectal neoplasms health literacy teach-back communication evidence based practice colonoscopy
sensory changes associated with thoracic surgery

Conditions: Thoracic Surgery

Summary: many patients experience chronic pain after thoracic surgery and this is caused by nerve damage during surgery. changes in skin sensation (dysaesthesia) is typically associated with chronic nerve pain. we hypothesise that thoracic surgery causes sensory changes. another hypothesis is that minimally invasive thoracic surgery using video cameras results in less nerve damage and so a smaller area of altered skin sensation, when compared to the traditional method of chest surgery using a large surgical incision. a final hypothesis is that the extent of nerve damage during surgery is associated with the severity of pain early after surgery. this study is designed to compare the total areas of sensory changes after thoracic surgery on the operated side of the chest with that on the non-operated side of the chest. we also aim to identify the type, pattern, location and area of sensory changes associated with thoracic surgery, comparing the operated with the non-operated side of the chest. in addition, we aim to compare the total area of sensory changes between the traditional method of chest surgery and the minimally invasive method of chest surgery. we would also like to determine whether the severity of pain early after surgery is associated with the area of sensory changes.


Eligibility criteria:
inclusion criteria: * patients 18 years old or older admitted for elective thoracic surgery exclusion criteria: * emergency thoracic surgery * thoracic surgery involving sternotomy * damage to the spinal cord and/ or intercostal nerves prior to surgery * neurological diseases that may alter the skin sensation to the chest wall such as multiple sclerosis and neuropathies, previous surgery of chest wall, a history of chronic pain